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Topiroxostat oral preparation and preparation method thereof

A technology of topinostat and oral preparations, applied in the field of topinostat oral preparations and its preparation, and the field of topinostat oral preparations, can solve problems such as unstable quality and low dissolution rate, and achieve accelerated dissolution rate and production The effect of simple process and high safety

Inactive Publication Date: 2015-04-22
CHANGSHA BAISHUN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Because topirestat is a drug that is almost insoluble in water, existing topirestat preparations have defects such as unstable quality and low dissolution rate

Method used

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  • Topiroxostat oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription of Topicastat Tablets (Specification: 20mg):

[0035] Topicastat 20.0 g

[0036] Lactose 42.0 g

[0037] Crospovidone 7.0 g

[0038] 4% hydroxypropyl cellulose (HPC-SL) aqueous solution amount

[0039] Magnesium stearate 0.7 g

[0040] A total of 1000 pieces were made

[0041] Preparation:

[0042] ① Processing of raw and auxiliary materials: Mix the prescribed amount of topicastat and lactose evenly, mill in a ball mill for 1 to 2 hours, take out, and pass through a 200-mesh standard sieve for use; crospovidone is sieved with an 80-mesh sieve for use;

[0043] 2. mix the supermicronized mixture of above-mentioned topinostat and lactose with 5g crospovidone;

[0044] ③ Add an appropriate amount of 4% hydroxypropyl cellulose aqueous solution, mix well, and make a soft material;

[0045] ④ Wet granulation: take the above-mentioned soft material and granulate it with a 24-mesh screen;

[0046] ⑤ Drying: Dry the above wet granules, and co...

Embodiment 2

[0051] Topicastat tablet core prescription (specification: 40mg):

[0052] Topicastat 40.0 g (dry and pure)

[0053] Lactose 45.0 g

[0054] Microcrystalline Cellulose 45.0 g

[0055] Croscarmellose Sodium 12.0 g

[0056] 4% hypromellose E15 aqueous solution amount

[0057] Micronized silica gel 1.5 g

[0058] A total of 1000 pieces were made

[0059] Coating Solution Prescription:

[0060] Opadry 85F42129 7.0 g

[0061] 75% ethanol 93.0 g

[0062] Preparation:

[0063] 1. Preparation of drug-containing tablet cores

[0064] ① Processing of raw and auxiliary materials: Mix the prescribed amount of topicastat with lactose and microcrystalline cellulose evenly, after ultra-micronization, pass through a 400-mesh standard sieve for later use; croscarmellose sodium is sieved through a 80-mesh sieve for later use ;

[0065] 2. Mix the supermicronized mixture of the above-mentioned topilastat with lactose and microcrystalline cellulos...

Embodiment 3

[0076] Topicastat tablet core prescription (specification: 60mg):

[0077] Topicastat 60.0 g (dry and pure)

[0078] Lactose 90.0 g

[0079] Microcrystalline Cellulose 30.0 g

[0080] Sodium starch glycolate 20.0 g

[0081] 8% povidone K30 aqueous solution amount

[0082] Magnesium stearate 2.0 g

[0083] A total of 1000 pieces were made

[0084] Coating Solution Prescription:

[0085] Opadry 85F18422 14.0 g

[0086] 75% ethanol 186.0 g

[0087] Preparation:

[0088] 1. Preparation of drug-containing tablet cores

[0089] ④ Processing of raw and auxiliary materials: Mix the prescribed amount of topicastat with lactose and microcrystalline cellulose evenly, after ultra-micronization, pass through a 400-mesh standard sieve for later use; sieve the croscarmellose sodium with a 80-mesh sieve spare;

[0090] ⑤ mix the supermicronized mixture of above-mentioned topilastat with lactose, microcrystalline cellulose and 16g croscarmell...

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Abstract

The invention provides a topiroxostat oral preparation and a preparation method thereof. The topiroxostat oral preparation is composed of an active ingredient topiroxostat as well as a filling agent, a disintegrating agent, a binding agent and a lubricating agent. The prepared topiroxostat oral preparation has no special requirement on particle size on the active ingredient, superfine grinding does not need to be carried out, energy consumption is low, dissolution rate reaches more than 95%, bioavailability is high, the defects of low dissolution rate and low bioavailability of the active ingredient are overcome, quality is stable and reliable, and a market development prospect is broad.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an oral preparation of topinastat and a preparation method thereof. The invention also provides an oral preparation of topinostat with high quality, safety and stability. Background technique [0002] The occurrence of gout is due to the excessive production of uric acid in the body and the decline in the ability of the kidneys to clear it. The accumulation of uric acid in the body leads to the deposition of urate crystals in the joints and various organs. With the continuous improvement of people's living standards, changes in dietary structure and living habits (increase in nucleoprotein-rich foods), the extension of average life expectancy, and the improvement of human understanding and diagnosis of gout, no matter in European and American countries or in Asia In all countries, the prevalence of gout is increasing year by year. At present, the number of patien...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/444A61P19/06
CPCA61K31/444A61K9/0053A61K9/2054A61K9/2866A61K9/4866
Inventor 不公告发明人
Owner CHANGSHA BAISHUN BIOTECH
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